(75 days)
Not Found
No
The summary describes a simple vacuum drainage system with no mention of AI/ML capabilities or data processing beyond standard quality control testing.
Yes
The device is intended for postoperative wound drainage to remove blood and secretions, which directly contributes to the healing process and prevents complications like hematomas and seromas, thus serving a therapeutic function.
No
The device is described as a vacuum source/waste container for postoperative wound drainage, used for removing blood and secretions. Its function is to drain fluids, not to diagnose conditions.
No
The device description explicitly states it is a "vacuum source/waste container," which are physical hardware components. The performance studies also mention "physical testing" of the finished product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for post-operative wound drainage, specifically to remove blood, secretions, and other fluids from wounds and body cavities. This is a physical process performed on the body, not a test performed on a sample in vitro (outside the body).
- Device Description: The device is described as a vacuum source/waste container for wound drainage. This aligns with the physical removal of fluids.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens (like blood, urine, tissue) obtained from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for the physical removal of fluids from a wound.
N/A
Intended Use / Indications for Use
The intended use of Redyrob is as a vacuum source / waste container utilized for post operative wound drainage. The indications for use for the device are to drain blood and secretions from wounds and body cavities for hematoma and surtma prophylaxes and for the removal of serosanguineous fluid and other harmful liquids.
Product codes (comma separated list FDA assigned to the subject device)
GCY
Device Description
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce REDYROB ®, Closed Wound Drainage System. REDYROB ® is a vacuum source/waste container utilized for postoperative wound drainage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4680 Nonpowered, single patient, portable suction apparatus.
(a)
Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
OCT - 1 1997
July 10, 1997
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
Mark S. Alsberge, Requlatory Affairs Manager Contact:
REDYROB ® Closed Wound Drainage System Product Name:
Apparatus, Suction, Single Patient Use, Portable, Nonpowered Trade Name:
Classification name:
General Hospital and Plastic Surgery Class :1. - 79 GCY 21 CRF 878.4680
SUBSTANTIAL EQUIVALENCE1 TO:
| 510(k) number | Name | Applicant |
|---|---|---|
| K883582 | Varidyne Model 250 Suction | |
| Drainage System | Surgidyne |
Device Description:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce REDYROB ®, Closed Wound Drainage System. REDYROB ® is a vacuum source/waste container utilized for postoperative wound drainage.
1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.
1
Material:
REDYROB ® is composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.
Substantial equivalence:
REDYROB ® is similar in intended use to the Varidyne Model 250 Suction Drainage System manufactured by Surgidyne. There are no new issues of safety or effectiveness raised by REDYROB ® Closed Wound Drainage System.
Safety And Effectiveness:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approve', released, distributed and revised in accordance with document control CGMP's.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT - 1 1997
Mr. Mark S. Alsberge .Regulatory Affairs Director B. Braun Medical, Inc. 824 Twelfth Avenue Bethlehem, Pennsylvania 18018-0027
Re: K972703
Trade Name: REDYROB® Closed Wound Drainage System Regulatory Class: I Product Code: GCY Dated: July 17, 1997 Received: July 18, 1997
Dear Mr. Alsberge:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Mark S. Alsberge
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
palla
lia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Dramage Redyrob - Closed Woung Device Name: oum Indications For Use:
The intended use of Redyrob is
as a vacuum source / waste container
utilized for post operative wound
drainage. The indications for use
for the device are to drain blood
and secretions from wounds and
body cavities for hematoma and
surtma prophylaxes and for the
removal of serosanguineous fluid
and other harmful liquids.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
loach
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K972703
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use .
(Optional Forrant 1-2-96)